AmyloidosisNCT07218705
A Study Of MCG In Cardiac Amyloidosis
An observational study of Amyloidosis, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary objective of this observational study is to evaluate the utility of magnetocardiography (MCG) in diagnosing and monitoring disease progression in patients with amyloidosis, and to assess its effectiveness in comparison to other modalities, such as ECG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- SandboxAQ CardiAQ Magnetocardiography
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study candidates may be identified and recruited in one of the following ways: * Amyloid Clinic (or other cardiology specialty clinics) * In-patient service at the study institution. * From the Principal Investigator or Co-Investigator clinical practices * Referral from other hospitals
Who may be able to join
- Age ≥ 18 years on the date of consent
- Ability for participant to comply with study requirements
- Written informed consent
Who cannot join
- Pregnant or breastfeeding
- Having an active atrial fibrillation episode as seen on most current 12-lead ECG
- Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillator).
- External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan
- Inability to lie down in a supine/inclined position and stay still on the examination bed
- Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Structural Heart Research Team, (507) 255-6133, konwinski.craig@mayo.edu
Mohamad Adnan Alkhouli, MD
About this study
Official title: A Prospective Study of Magnetocardiography for Disease Detection and Monitoring Treatment Outcomes in Amyloidosis
The primary objective of this observational study is to evaluate the utility of magnetocardiography (MCG) in diagnosing and monitoring disease progression in patients with amyloidosis, and to assess its effectiveness in comparison to other modalities, such as ECG.
- Conditions
- Amyloidosis
- Being tested
- SandboxAQ CardiAQ Magnetocardiography
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SandboxAQ CardiAQ MagnetocardiographyDevice
Magnetocardiography is a non-invasive, radiation-free imaging technique that detects the magnetic field generated by the electrical activity of the heart.
| Study group | Role | What they receive |
|---|---|---|
| Patients with amyloidosis | Not described Receives: Device: SandboxAQ CardiAQ Magnetocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receiver Operating Characteristic (ROC) curve
Receiver Operating Characteristic (ROC) curve is used to compare true positive rate vs false positive rate. This will be used to determine the sensitivity, specificity, and overall effectiveness of MCG.
Measured: Baseline, 6 Months, 12 Months, 18 Months
Area Under the Curve (AUC) Magnetocardiography
Area Under the Curve (AUC) will be measured by mg*h/L.
Measured: Baseline, 6 Months, 12 Months, 18 Months
Area Under the Curve (AUC) Electrocardiogram
Area Under the Curve (AUC) will be measured by mg*h/L.
Measured: Baseline, 6 Months, 12 Months, 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start3 Dec 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Adnan Alkhouli, Mayo Clinic
- Investigators
- Mohamad Alkhouli, M.D., M.B.A., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218705
- Sponsor's protocol ID
- 25-005053
- Status last verified
- Dec 2025
- First submitted
- 16 Oct 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Magnetocardiography for Disease Detection and Monitoring Treatment Outcomes in Amyloidosis
- ClinicalTrials.gov ID
- NCT07218705
- Acronym / sponsor ID
- 25-005053
- Conditions
- Amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this observational study is to evaluate the utility of magnetocardiography (MCG) in diagnosing and monitoring disease progression in patients with amyloidosis, and to assess its effectiveness in comparison to other modalities, such as ECG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with amyloidosis | – | Device: SandboxAQ CardiAQ Magnetocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study candidates may be identified and recruited in one of the following ways: * Amyloid Clinic (or other cardiology specialty clinics) * In-patient service at the study institution. * From the Principal Investigator or Co-Investigator clinical practices * Referral from other hospitals
Key inclusion criteria (3 listed)
- Age ≥ 18 years on the date of consent
- Ability for participant to comply with study requirements
- Written informed consent
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding
- Having an active atrial fibrillation episode as seen on most current 12-lead ECG
- Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillator).
- External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan
- Inability to lie down in a supine/inclined position and stay still on the examination bed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SandboxAQ CardiAQ MagnetocardiographyMagnetocardiography is a non-invasive, radiation-free imaging technique that detects the magnetic field generated by the electrical activity of the heart. | Device | Patients with amyloidosis |
Primary outcome
Receiver Operating Characteristic (ROC) curve
Time frame: Baseline, 6 Months, 12 Months, 18 Months
Receiver Operating Characteristic (ROC) curve is used to compare true positive rate vs false positive rate. This will be used to determine the sensitivity, specificity, and overall effectiveness of MCG.
Area Under the Curve (AUC) Magnetocardiography
Time frame: Baseline, 6 Months, 12 Months, 18 Months
Area Under the Curve (AUC) will be measured by mg*h/L.
Area Under the Curve (AUC) Electrocardiogram
Time frame: Baseline, 6 Months, 12 Months, 18 Months
Area Under the Curve (AUC) will be measured by mg*h/L.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamad Alkhouli, M.D., M.B.A. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andy Dang (507-255-7752, dang.phong@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receiver Operating Characteristic (ROC) curve (time frame: Baseline, 6 Months, 12 Months, 18 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.